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Paradigm 1200016

by Proprio

Paradigm 1200016 is a Class II device made by Proprio, cleared under FDA 510(k) K252950 on 15 Dec 2025 (2 earlier submissions) and listed in FDA GUDID since 21 Mar 2025 (UDI-DI 00850042604199), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK252950 Date15 Dec 2025DecidedStatusActive
United StatesGUDID listing Number00850042604199 UDI-DI Date21 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252950 decided 15 Dec 2025 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00850042604199 listed 21 Mar 2025 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K243258
  2. Listed FDA GUDID 00850042604199
  3. Cleared FDA 510(k) K250879
  4. Cleared FDA 510(k) K252950

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Paradigm
Generic name
Optical surgical tracking system spatial marker, reusable
Model / Ref / Catalog
1200016
Primary DI / UDI-DI
00850042604199
510(k) Number
FDA product code
OLO
GMDN term
Optical surgical tracking system spatial marker, reusable
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Related devices

Category: Surgical optical-tracking spatial marker, reusable

Cleared under the same submission (K243258)

and 8 more cleared under K243258

Cleared under the same submission (K250879)

and 8 more cleared under K250879

Similar devices

Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).

Other devices from Proprio

See all devices from Proprio →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)